Bioequivalence and Bioavailability Forum

Dear all,

as a reminder: The guideline was adopted by the EMA on 23 July 2024 and is effective with 25 January 2025 – superseding applicable parts of the 2010 BE guideline related to design considerations and data ana­ly­sis for non-replicate studies. See this thread for changes to the draft.

Some requirements are beyond my comprehension…

• For all IR products AUC_0−72h (instead of AUC_0−t) was acceptable for the EMA and is for the WHO. Makes sense.*
  
• The FDA, Health Canada, and members of the ICH (which implemented the guideline) accept that only for drugs with a half-life of > 24 hours. Why the heck?

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• Residence time in the GI tract and, thus, limiting potential absorption is independent from elimination. It was confirmed in many studies (by scintigraphy, magnetic marker monitoring) to be not more than three days. That was the justification for truncation of the AUC at 72 hours.